Control of Medicines (Report) (Hansard, 14 April 1988)

§ Mr. Newton

Dr. Evans and Mr. Cunliffe found thatthe overall record of medicines control in the United Kingdom is a good one and its reputation stands deservedly high and concluded that the DHSS record in protecting the public without inhibiting therapeutic innovation and progress is second to none. They also noted that the Department has handled the growing burden of licensing work with commendable increase in efficiency. At the same time they made a number of criticisms of the organisation and working practices of the medicines division, and also commented on the room for improvement by the pharmaceutical industry in the submission of licence applications. They made 54 recommendations. We have consulted the Medicines Commission on key proposals and I can now set out the conclusions we have so far reached.

I accept Dr. Evans' and Mr. Cunliffe's recommendation that the responsibility for the control of medicines should remain in DHSS and that the Medicines Control Agency, as it will be known, should be under the charge of a single director. I also accept that the work of the agency should be organised in functional teams and that these should be supported by suitable information technology. The actual structure of the agency will not be determined until after the director has been appointed.

I accept in principle the recommendation that the whole cost of the agency should be met from licence fees and we will now discuss this with the trade associations. It will be necessary to establish arrangements to show the industry that the cost of the agency is no more than is required for the tasks it has to carry out. I do not, however, propose to accept the recommendations for a budget committee on which the industry would be represented. As Dr. Evans and Mr. Cunliffe pointed out, the Department must remain independent of the industry in carrying out its licensing work. It will more easily be seen to be so if, instead of setting up a committee on which both parties were represented, the Department arranged meetings with the industry as required to explain the basis for the levels of fees it proposed and to discuss the management performance of the agency. These arrangements will in no way impinge on the agency's independence of the industry in carrying out its responsibilities for controlling medicines.

The first priority must be to appoint the director and I am taking action to this end. My intention is that the main managerial and financial changes should be made well in time for the financial year 1989–90. In the meantime the Department is pursuing the other recommendations in the Evans-Cunliffe report.

I am grateful to Dr. Evans and Mr. Cunliffe for their report. I believe they have shown ways, in their words, "to make a good system better" and of enabling the Department to cope with further increases in licensing and other work on the control of medicines. Improvements in the management of the work will benefit patients and will further our objective of promoting investment by research-based pharmaceutical companies in this country.